Office of Research & Regulatory Affairs (IRB)

The mission of Cook County Health’s Institutional Review Board (IRB) is to protect human participants involved in research conducted by or through Cook County Health and to ensure all research is conducted in accordance with ethical principles and all applicable regulations.

The IRB serves as the Board of Record for all Cook County Health affiliates.  
The Office of Research & Regulatory Affairs provides: administrative support to the IRB; review process for all protocol applications; feedback to investigator; correspondence with investigators; educational programs and audits.  
Federal Wide Assurance (FWA) 
Cook County Health IRB has filed a Federal Wide Assurance (FWA) with the Department of Health and Human Services (DHHS), in which we promise to uphold federal regulations and ethical principles for human participants in research conducted by employees, agents and affiliates of Cook County Health. 
FWA number: FWA00001802 
IRB Registration Information Letter (IORG) 
The Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) require IRBs to register through a system maintained by DHHS. 
IRB Organization (IORG) number: IORG0000119 

Guide for Investigators

The Guide for Investigators is an effort to describe expectations and provide some operational guidance for the ethical conduct of research done at all affiliates of Cook County Health. 
Guide for Investigators 

IRB Manager

IRB Manager, our web-based submission system, allows users to enter protocols and protocol related information such as: new submissions, progress reports, adverse events, attachments, comments and more. Investigators have access to see the protocols they’re investigating as well as attachments, events and documents generated for their study. 

https://cchhs.my.irbmanager.com/Login.aspx 
User Manual 
Quick Sheet 

Please email  CCHHSIRB@cookcountyhealth.org  at the Office of Research & Regulatory Affairs to obtain a login and password. If you need assistance or would like to schedule a training session, please send an email to the address above. 

Templates & Forms

Templates

Forms 

Newsletters & Other Links

Newsletters 
Workshop Slides 
IRB Meeting Calendar 2019
Roster for IRB

Related Links 

Human Participant Research

Training for Human Participant Research

All persons who are to be substantively involved in human participant research at Cook County Health must be properly trained.
This process involves completing the self-guided tutorial with the aid of the Guidelines for Investigators and attending an in–person training session. 
You must have a Cook County Health ID to attend this session. If you are an outside investigator, you must first complete the onboarding process.  
For investigators who are not affiliated with Cook County Health and have completed human participant research training at their home institution, this may be substituted for the Cook County Health training session with documentation of such. 
To enroll in a training session, please email CCHHSIRB@cookcountyhealth.org. 
Cook County Health Guidelines for Investigators 
Cook County Health Self-Guided Tutorial 

Audits of Human Participant Research

The Office of Research & Regulatory Affairs conducts audits on research projects involving human participants.
Two types of audits are conducted: random post-approval monitoring audits and for-cause audits, which are a tool to provide insight to research related conduct at Cook County Health and achieve compliance with applicable federal regulations and laws as well as Cook County Health policies and procedures. Audits are also a vehicle for quality improvement, awareness of operations and continuing education. 
The purpose of the audit is to review and inspect the ethical conduct of human participant research, adherence to the study protocol, and adherence to what is presented to the IRB as well as to participants in the informed consent process. Audits typically involve the review and inspection of informed consent forms, HIPAA authorization forms, IRB records, training documentation and data management/documentation with an emphasis on confidentiality and privacy procedures. Please click on the link below to access a checklist to help you prepare for your audit. 
Cook County Health Audit Checklist 

Fee Schedule

The Office of Research & Regulatory Affairs charges a processing/administrative fee for the Cook County Health IRB review of all industry sponsored human participant research.
IRB review fees are not charged for non-profit sponsored studies supported by the National Institutes of Health (NIH), other government agencies, foundations, or investigator-initiated studies. A one–time fee will be charged for the review of any new industry funded studies. There will be no charge for renewals, amendments/modifications, protocol deviations, unanticipated events involving risk, or final reports. Please click on the link below to access the current fee structure. These fees are subject to review and change. 
Cook County Health Fee Structure Memo 

Program Contact

Office of Research & Regulatory Affairs
(312) 864-4823
(312) 864-9210
Email

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